Description of Event or Problem · 0
EVENT VERBATIM [PREFERRED TERM] EMBOLIZATION WITH HAND-CUT, 1-MM DIAMETER GELATIN SPONGE (GELFOAM) [OFF LABEL USE], EMBOLIZATION WITH HAND-CUT, 1-MM DIAMETER GELATIN SPONGE (GELFOAM) [DEVICE USE ISSUE], BILOMA FORMATION AFTER REPEATED TACE IN ONE PATIENT [BILOMA]. NARRATIVE: THIS IS A LITERATURE REPORT FOR THE FOLLOWING LITERATURE SOURCE(S): "SAFETY AND EFFICACY OF TRANSARTERIAL CHEMOEMBOLIZATION FOR CAUDATE LOBE HEPATOCELLULAR CARCINOMA: LONG-TERM CLINICAL OUTCOMES.", JOURNAL OF VASCULAR &INTERVENTIONAL RADIOLOGY, 2025; DOI:10.1016/J.JVIR.2025.09.038. AN ADULT PATIENT RECEIVED ABSORBABLE GELATIN (GELFOAM), INTRA-ARTERIAL FOR THERAPEUTIC EMBOLISATION. THE PATIENT'S RELEVANT MEDICAL HISTORY INCLUDED: "SINGLE CAUDATE LOBE HEPATOCELLULAR CARCINOMA (HCC)" (ONGOING). CONCOMITANT MEDICATION(S) INCLUDED: CISPLATIN INTRAARTERIAL TAKEN FOR THERAPEUTIC EMBOLISATION, HEPATOCELLULAR CARCINOMA; LIPIODOL INTRA-ARTERIAL TAKEN FOR THERAPEUTIC EMBOLISATION, HEPATOCELLULAR CARCINOMA. THE FOLLOWING INFORMATION WAS REPORTED: OFF LABEL USE (INTERVENTION REQUIRED, MEDICALLY SIGNIFICANT), DEVICE USE ISSUE (INTERVENTION REQUIRED, MEDICALLY SIGNIFICANT), OUTCOME "UNKNOWN" AND ALL DESCRIBED AS "EMBOLIZATION WITH HAND-CUT, 1-MM DIAMETER GELATIN SPONGE (GELFOAM)"; BILOMA (INTERVENTION REQUIRED, MEDICALLY SIGNIFICANT), OUTCOME "UNKNOWN", DESCRIBED AS "BILOMA FORMATION AFTER REPEATED TACE IN ONE PATIENT". CLINICAL COURSE: THIS RETROSPECTIVE STUDY WAS CONDUCTED TO EVALUATE THE SAFETY AND EFFECTIVENESS OF TRANSARTERIAL CHEMOEMBOLIZATION (TACE) AS A FIRST-LINE TREATMENT IN 107 PATIENTS WITH A SINGLE HEPATOCELLULAR CARCINOMA (HCC) TUMOR LOCATED IN THE CAUDATE LOBE (SINGLE CAUDATE LOBE HEPATOCELLULAR CARCINOMA) WITH LONG-TERM FOLLOW-UP. A TOTAL OF 3492 TREATMENT-NAIVE PATIENTS WHO RECEIVED CHEMOEMBOLIZATION BETWEEN JANUARY 2006 AND DECEMBER 2023 AS FIRST-LINE TREATMENT FOR SINGLE HCC WERE IDENTIFIED. AMONG THESE 3492 PATIENTS, 107 HAD AN HCC LOCATED IN THE CAUDATE LOBE AND WERE ANALYZED IN THIS STUDY. THE SUBSEGMENTAL LOCATIONS OF THE 107 HCCS WERE THE SPIEGEL LOBE (N = 57), THE PARACAVAL PORTION (N = 39), AND THE CAUDATE PROCESS (N = 11). TACE WAS PERFORMED BY ONE OF EIGHT EXPERIENCED INTERVENTIONAL RADIOLOGISTS, EACH WITH AT LEAST 10 YEARS OF EXPERIENCE WITH CHEMOEMBOLIZATION. SUPERIOR MESENTERIC AND CELIAC ARTERIOGRAPHY WAS INITIALLY PERFORMED USING A 5-F CATHETER (ROSCH HEPATIC CATHETER; COOK, BLOOMINGTON, INDIANA) TO ASSESS THE ANATOMY, TUMOR BURDEN, AND PORTAL VEIN PATENCY. ADDITIONAL DIGITAL SUBTRACTION ANGIOGRAMS OF RIGHT AND LEFT HEPATIC ARTERIES WERE OBTAINED TO IDENTIFY THE ARTERIES FEEDING THE CAUDATE LOBE HCC. IF REQUIRED, CONE-BEAM CT WAS USED TO IDENTIFY TUMOR-FEEDING CAUDATE ARTERIES (N = 8). CISPLATIN-BASED CHEMOEMBOLIZATION (DOSE: 2 MG/KG OF BODY WEIGHT) WAS PERFORMED USING A 1.7 (N = 25), 1.8 (N = 23), 1.9 (N = 5), 2.0 (N = 28), 2.2 (N = 7), AND 2.4 (N = 19)-F MICROCATHETER (PROGREATTM/PROGREAT LAMBDA, TERUMO, TOKYO, JAPAN; RENEGADE, BOSTON SCIENTIFIC, MARLBOROUGH, MASSACHUSETTS; CARNELIAN, TOKAI MEDICAL PRODUCTS, KASUGAI-CITY, JAPAN) AND MICROGUIDEWIRE (TRANSEND, BOSTON SCIENTIFIC, MARLBOROUGH, MASSACHUSETTS; MEISTER, ASAHI INTECC, SETO-SHI, JAPAN). A 1:1 EMULSION OF CISPLATIN (DISSOLVED IN SALINE) AND IODIZED OIL (LIPIODOL, GUERBET) WAS INFUSED INTO THE FEEDING ARTERY, FOLLOWED BY EMBOLIZATION WITH HAND-CUT, 1-MM DIAMETER GELATIN SPONGE (GELFOAM, PFIZER, NEW YORK CITY, NEW YORK) OR CALIBRATED (CALI-GEL [150-350 UM OR 350-560 UM IN DIAMETER], HANGZHOU ALICON PHARM SCI. & TEC., HANGZHOU, CHINA; OR NEXSPHERE [100-300 UM OR 300-500 UM IN DIAMETER], NEXT BIOMEDICAL, INCHEON, SOUTH KOREA) GELATIN PARTICLES UNTIL ARTERIAL FLOW STASIS WAS ACHIEVED. POSTEMBOLIC CELIAC ARTERIOGRAPHY WAS PERFORMED TO ENSURE NO VIABLE TUMOR OR ADDITIONAL FEEDING ARTERY EXISTED. PATIENTS WERE INITIALLY FOLLOWED-UP AT 1 MONTH AFTER TACE WITH LABORATORY TESTS AND CONTRAST-ENHANCED COMPUTED TOMOGRAPHY (CT) OR MAGNETIC RESONANCE IMAGING (MRI). PATIENTS WERE THEN SUBSEQUENTLY FOLLOWED UP EVERY 2-3 MONTHS DURING THE FIRST 2 YEARS, AND THEN EVERY 3-6 MONTHS UNTIL HCC RECURRENCE. TACE WAS REPEATED IN PATIENTS WHO SHOWED AN INSUFFICIENT RESPONSE AFTER A SINGLE SESSION AND IN THOSE WITH RECURRENT TUMORS. IN SOME PATIENTS WITH RESIDUAL OR LOCALLY RECURRENT CAUDATE LOBE HCC FOLLOWING REPEAT TACE, STEREOTACTIC BODY RADIATION THERAPY, OR PERCUTANEOUS ETHANOL INJECTION WERE TREATED WITH ADDITIONAL TACE. SOME PATIENTS WITH NEW TUMORS AT OTHER LIVER SITES DURING FOLLOW-UP WERE TREATED WITH RADIOFREQUENCY ABLATION IF THEY MET THE CRITERIA FOR RADIOFREQUENCY ABLATION. OF THE 107 PATIENTS, 3 (2.8%) EXPERIENCED A SEVERE ADVERSE EVENT. THIS CASE REFERS TO THE PATIENT WITH FOLLOWING EVENT "BILOMA FORMATION AFTER REPEATED TACE IN ONE PATIENT". THE PATIENT UNDERWENT THE FOLLOWING LABORATORY TESTS AND PROCEDURES: ALPHA 1 FOETOPROTEIN: UNKNOWN RESULT; ARTERIOGRAM: UNKNOWN RESULT; COMPUTERISED TOMOGRAM: UNKNOWN RESULT; HEPATITIS B VIRUS TEST: UNKNOWN RESULT; HEPATITIS C VIRUS TEST: UNKNOWN RESULT; CHILD-PUGH SCORE: UNKNOWN RESULT; TUMOR SIZE: UNKNOWN RESULT, NOTES: CM; LABORATORY TEST: UNKNOWN RESULT; MAGNETIC RESONANCE IMAGING: UNKNOWN RESULT. THE ACTION TAKEN FOR ABSORBABLE GELATIN WAS UNKNOWN. CAUSALITY FOR "EMBOLIZATION WITH HAND-CUT, 1-MM DIAMETER GELATIN SPONGE (GELFOAM)" AND "BILOMA FORMATION AFTER REPEATED TACE IN ONE PATIENT" WAS DETERMINED ASSOCIATED TO ABSORBABLE GELATIN (MALFUNCTION)., COMMENT: THE EVENT BILOMA IS ASSESSED AS SERIOUS, ASSOCIATED WITH THE PRODUCT ABSORBABLE GELATIN (GELFOAM), AND UNLISTED IN THE CDS OF THE PFIZER SUSPECT PRODUCT ABSORBABLE GELATIN. THE INJURY FROM THE MEDICAL PROCEDURE TRANSARTERIAL CHEMOEMBOLIZATION ITSELF HAS BEEN ASSESSED TO BE AN ALTERNATIVE CAUSE FOR THE EVENT. THIS CASE WILL BE REASSESSED WHEN ADDITIONAL INFORMATION IS RECEIVED.